China Drug Regulatory Update

This virtual program will provide an overview of drug regulation in China, including eligibility and the steps required to register a new drug product with the NMPA. It will outline the timelines and fees associated with bringing drug products to market in China, along with the required clinical trials and necessary regulatory documentation. 

The expert presenter will review Drug Master Files (DMF) for excipient, API, and drug packaging materials, reimbursement options, and China's rare disease list and orphan drugs. Lastly, the program will explore expedited registration pathways in the Hainan Province.

Pricing Amounts & Deadlines

Early Bird: Member: $150 | Non Member: $175
Regular: Member: $175 | Non Member: $200

Agenda

This workshop will cover the following topics:
1. China registration -- who can do it?
2. Drug registration steps
3. Drug regulatory documents
4. Clinical trials
5. Registration timelines and fees
6. Drug Master Files (DMF) for excipient, API, and drug packaging materials
7. Reimbursement
8. China's rare disease list and orphan drugs
9. Expedited registration pathways via Hainan Island

Audience Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Learning Objectives:

• Know how to register a drug in China
• Understand the steps required for drug registration
• Know clinical trials are required for drug registration
• Understand what reimbursements are available for drugs in China

Who Should Attend:

RA/QA professionals at drug and biotech companies; business development executives at drug and biotech companies.

Instructors:

Ames Gross
President and Founder
Pacific Bridge Medical

Mr. Gross founded Pacific Bridge Medical in 1988 and has helped hundreds of medical companies with regulatory issues and business development in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. In 2008, Medical Device and Diagnostic Industry (MD&DI) magazine named Mr. Gross one of the top 100 executives in the medical business. Mr. Gross is a frequent contributor of articles on Asian medical issues for RAPS, Clinica (England), MD&DI (Los Angeles), and other medically oriented journals. He has been a featured speaker on the Asian medical markets at the Medical Design and Manufacturing (MD&M) shows, the Medtrade Home Health Care Exhibition, the Regulatory Affairs Professional Society’s annual and regional meetings, and a variety of other medically oriented meetings and conferences.Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the webcast.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org